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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00203931 |
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Date of registration:
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12/09/2005 |
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Primary sponsor: |
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Public title:
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Trial Comparing Cetuximab With Pemetrexed/Cetuximab Therapy for Non-Small Cell Lung Cancer
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Scientific title:
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A Randomized Phase II Trial Comparing Cetuximab With Concurrent Pemetrexed/Cetuximab Therapy for Non-Small Cell Lung Cancer Refractory to Primary Treatment |
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Date of first enrolment:
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March 2005 |
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Target sample size:
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53 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00203931 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Michael Maitland, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Chicago |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of locally advanced or metastatic (Stage III or IV at entry) non-small cell
lung cancer (NSCLC) that is not amenable to curative therapy.
- ECOG performance status 0-2
- Patients must have been previously treated with one platinum-containing or
taxane-containing chemotherapy regimen for locally advanced or metastatic disease.
Patients are also eligible if they have received one platinum-based chemotherapy
regimen as neoadjuvant or adjuvant chemotherapy, but must have received an additional
chemotherapy regimen upon recurrence.
- No more than two prior systemic anti-cancer therapies will be allowed.
- Prior radiation therapy is allowed to <25% of the bone marrow. Prior radiation to the
whole pelvis is not allowed, Prior radiotherapy must be completed at least 2 weeks
before study enrollment, and the patient must have recovered from the acute toxic
effects of the treatment prior to study enrollment.
- Patients must have signed an approved informed consent.
- Male and female patients with reproductive potential must use an approved
contraceptive method if appropriate (eg, intrauterine device, birth control pills, or
barrier device) during and for 3 months after the study. Female patients must either
not be of child bearing potential or have a negative pregnancy test within 7 days of
treatment. Patients are considered not of child bearing potential if they are
surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or
bilateral oophorectomy) or they are postmenopausal.
- Age>18
- Measurable disease in accord with RECIST criteria
- Bone marrow Function: absolute neutrophil count (ANC)>/=1,500/ul, platelets
>/=l00,000, hemoglobin> 9g/dL
- Renal function: creatinine clearance (calculated by Cockcroft and Gault method) >/=
45mL/min
- Hepatic function: bilirubin /=2.5 g/dL
Exclusion Criteria:
- Prior treatment with pemetrexed
- Prior therapy that targets the EGF pathway.
- Active or uncontrolled infection.
- Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension,
unstable angina, and congestive heart failure.
- Pleural or pericardial effusions that cannot be completely evacuated prior to
pemetrexed therapy.
- Acute hepatitis or known HIV.
- Prior severe infusion reaction to a monoclonal antibody.
- Any concurrent chemotherapy not indicated in the study protocol or any other
investigational agent(s).
- Pregnancy or Breast-feeding.
- Second primary malignancy that is clinically detectable at the time of consideration
for study enrollment.
- Inability to interrupt aspirin, or other nonsteroidal anti-inflammatory agents for a
5-day period.
- Inability or unwillingness to take folic acid or vitamin B12 supplementation.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Non-small Cell Lung Cancer
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Intervention(s)
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Drug: Cetuximab
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Drug: Cetuximab and Pemetrexed
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Primary Outcome(s)
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To determine in patients with NSCLC refractory to previous chemotherapy whether concomitant treatment with cetuximab and pemetrexed improves progression-free survival compared with cetuximab monotherapy.
[Time Frame: 8 weeks, 11 weeks, 14 weeks, 20 weeks, every 6-8 weeks thereafter]
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Secondary Outcome(s)
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To compare objective response rates between combined cetuximab/pemetrexed therapy and cetuximab alone
[Time Frame: Every Cycle - Days 8 and 15]
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To compare overall survival in patients treated with combined cetuximab/pemetrexed vs. sequential therapy with cetuximab followed by pemetrexed.
[Time Frame: Study days 34-40 and continue every 21 days]
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To evaluate prospectively the utility of early rash in predicting outcome (progression-free survival time) to second-line NSCLC treatment.
[Time Frame: Prior to each cycle]
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To identify a serum polypeptide signature predicting tumor response to cetuximab-containing therapy.
[Time Frame: Samples collected at enrollment & prior to 3rd dose of cetuxiimab therapy.]
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To produce a material collection which may confirm an mRNA expression array signature categorizing activity of EGFR inhibitor therapy
[Time Frame: Skin Biopsies at enrollment & after 2 weeks of cetuximab therapy.]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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